JP-2022502448-A5 -

Dates

Publication Date

20221206

Application Date

20190930

Description

A third aspect of the present invention provides a pharmaceutical composition comprising (1) a compound described in the first aspect of the present invention or a stereoisomer or tautomer thereof, or a pharmaceutically acceptable salt, hydrate or solvate thereof, and (2) a pharmaceutically acceptable carrier . The pharmaceutical composition of the present invention comprises a safe and effective amount of the compound of the present invention and a pharmaceutically acceptable excipient or carrier . Here, “safe and effective amount” means that the amount of the compound is sufficient to significantly improve the condition without causing serious side effects. Generally, the pharmaceutical composition contains 1 to 2000 mg of the compound of the present invention per drug, more preferably 10 to 200 mg of the compound of the present invention per drug. Preferably, “per drug” is one capsule or tablet. "Pharmacologically acceptable carrier " means one or more compatible solid or liquid fillers or gels that are suitable for human use and must have sufficient purity and sufficiently low toxicity. "Compatibility" means that each component in the composition can be mixed with and among the compounds of the present invention without significantly reducing the potency of the compounds. Examples of pharmaceutically acceptable carriers include cellulose and its derivatives (e.g., sodium carboxymethylcellulose, sodium ethylcellulose, cellulose acetate, etc.), gelatin, talc, solid lubricants (e.g., stearic acid, magnesium stearate), calcium sulfate, and vegetable oils (e.g., soybean oil, sesame oil). Oils, peanut oil, olive oil, etc.), polyols (e.g., propylene glycol, glycerin, mannitol, sorbitol, etc.), emulsifiers (e.g., Tween®), wetting agents (e.g., sodium lauryl sulfate), coloring agents, fragrances These include agents, stabilizers, antioxidants, preservatives, and pyrogen-free water. The method of administering the compound or pharmaceutical composition of the present invention is not particularly limited, and typical methods of administration include (but are not limited to) oral, parenteral (intravenous, intramuscular, or subcutaneous), and intratumoral administration. Solid dosage forms for oral administration include capsules, tablets, pills, powders, and granules. In these solid dosage forms, the active compound is mixed with at least one conventional inactive excipient (or carrier ), such as sodium citrate or dicalcium phosphate, or (a) fillers or compatibilizers such as starch, lactose, sucrose, glucose, mannitol and silicic acid, (b) hydroxymethylcellulose, alginate, gelatin, polyvinylpyrrolidone, sucrose and gum arabic. (c) Binders such as arabic, (d) Humectants such as glycerin, (e) Disintegrants such as agar, calcium carbonate, potato starch or tapioca starch, alginic acid, certain complex silicates, and sodium carbonate, (f) Soothing solvents such as paraffin It is mixed with components such as (g) absorption accelerators such as (h) cetyl alcohol and glyceryl monostearate as wetting agents, (i) kaolin as an adsorbent, and (g) talc, calcium stearate, magnesium stearate, solid polyethylene glycol, sodium lauryl sulfate, or mixtures thereof. In capsules, tablets, and pills, the dosage form may also include a buffer. Compositions for parenteral injection may include physiologically acceptable sterile aqueous or non-aqueous solutions, dispersions, suspensions, or emulsions, and sterile powders that can be reconstituted into sterile injectable solutions or dispersions. Suitable aqueous and non-aqueous carriers , diluents, solvents, or excipients include water, ethanol, polyols, and suitable mixtures thereof.